BACTERIAL ENDOTOXIN TEST FOR DEXAMETHASONE INJECTION
1.0 EQUIPMENT REQUIRED
LAF, Heating Block, Cyclo Mixer, Micropipettes,
2.0 MATERIAL REQUIRED
CSE,
LYSATE,
LRW,
Depyrogenated dilution tube 13mm X 100mm,
Depyrogenated assay tube 12mm X 75mm,
Individually packed Sterile, Endotoxin free micropipette tips.
3.0 General:
3.1 Clean all the required glassware and dehydrogenated all the glassware.
3.2 Transfer all the dehydrogenated all the glassware to BET room.
3.3 Switch on the heating block and set the temperature at 37°C.
4.0 Calculation Of Maximum Valid Dilution and preparation of product dilution to MVD/2.
4.1 Product will be tested at MVD.
4.2 Calculate MVD for sample specimen by following formula –
For this take 100 µl of sample and add to it 900 µl LRW & mix for three minutes using vortex mixer. Now take 100 µl from last dilution and add to it 68 µl LRW. this will be the product diluted to MVD/2.
5.0 Preparation of Control Standard Endotoxin (CSE)
5.1 Reconstitute CSE in LRW as per manufacturers instruction as laid down in the bottle and
certificate supplied by manufacturer, and vortex for 30 minutes intermittently.
5.2 Use Reconstituted CSE within 4 weeks after reconstitutions. Store reconstituted CSE at 20C to 80C temperature.
5.3 Prepare a CSE dilution with LRW to yield 1EU/ml and shake the dilution on vortex for 3 minutes. Prepare 4 CSE by diluting a volume from 1 EU/ml CSE with LRW. For this take 200 µl of 1 EU/ml CSE and add to it 200 µl LRW. This will be 4 CSE.
5.4 Shake the dilution on vortex mixer for 3 minutes.
6.0 Reconstitution of Lysate
6.1 Now reconstitute the Lysate by opening the aluminum seal of Lysate with the help of sterile blade.
6.2 Collect Lysate powder into the bottom of the vial by tapping on a hard surface. And then open the cork slowly.
6.3 As per manufacturer’s instruction, add LRW or buffer solution before use and replace the cork immediately.
7.0 Test Procedure
7.1 Prepare solutions A, B, C and D as shown in Table 1,
| Solution | Solution description | LRW in ml | 4l (CSE) in ml | Product at MVD/2 in ml | Lysate in ml | No. of Replicates |
| A | Negative product control (NPC) | 50 | – | 50 | 100 | 2 |
| B | Positive Product control (PPC) | – | 50 | 50 | 100 | 2 |
| C | Positive water control (PWC) | 50 | 50 | – | 100 | 2 |
| D | Negative water control (NWC) | 100 | – | – | 100 | 2 |
- Take 8 dehydrogenated4ererer assay tubes and label the tubes by numbering and arrange in stand one opposite to each other. i.e. 1 & 2 for NPC, 3 & 4 for PPC, 5 & 6 for PWC, 7 & 8 for Negative water control.
- Add 50ml of LRW in NPC and PWC, and 100 ml in NWC. Immediately add 50 ml of product sample, which is diluted at MVD/2 in a NPC and PPC, and then add 50ml of CSE that is diluted to 4l in a PPC and PWC.
- Finally add 100ml of Lysate in all tubes and next, mix the assay tubes by hand and incubate in heating block, where the temperature is maintained at 37 ± 10C for 60 ± 2
- Interpretation of Result
- Each tube in the gel clot method is interpreted as either positive or negative, Positive test indicates the formation of firm gel capable of maintaining its integrity when the test tube is inverted 1800.
- A negative test is characterized by the absence of gel or by the formation of a viscous mass, which does not hold when the tube is inverted at 1800.
- The test is not valid if the positive product control is negative or if the negative control is
Analysis of vitamin B1 B6 B2 Nicotinamide and sodium pentothenate Injection
Analysis for Nandrolone Decanoate injection
Analysis of Dicyclomine and Diclofenac sodium Injection
standard testing procedure of Fexofenadine and Phenylephrine suspension
standard testing procedure of Piroxicam Injection
STP of Fungal Diastase and Papain capsules
standard testing procedure PVC
standard testing procedure glass ampoule
Standard testing procedure of Iron Sucrose Injection
Standard testing procedure lactose
Standard testing procedure mefenamic acid
standard testing procedure domperidone
standard testing procedure flavour mixed fruit
standard testing procedure dicyclomine hydrochloride
Standard testing procedure honey pure
standard testing procedure dextromethorphan hydrobromide
standard procedure of levocarnitine injection
Analysis of Ivermectin Suspension
standard testing procedure artemether injection
standard testing procedure artemether injection
standard testing procedure Carbocisteine syrup
standard testing procedure Phytomenadione injection
standard testing procedure serratiopeptidase
standard testing procedure starch IP
standard testing procedure sucrose refined sugar
standard testing procedure titanium dioxide
standard testing procedure tramadol hydrochloride
standard testing procedure zinc sulphate
standard testing procedure croscarmellose sodium
standard testing procedure colour erythrosine supra
standard testing procedure magnesium hydroxide
standard testing procedure diclofenac sodium
standard testing procedure dibasic calcium phosphate
standard testing procedure cyanocobalamin
standard testing procedure cholecalciferol
standard testing procedure Calcium carbonate oyster shell powder
standard test procedure Calcium Citrate
standard testing procedure Bronopol
standard testing procedure Bromhexine Hydrochloride
Standard Testing Procedure diclofenac sodium injection
Standard Testing Procedure Drotaverine Hydrochloride injection
Standard Testing Procedure Tranexamic acid injection
standard test procedure paracetamol infusion
standard test procedure ofloxacin and ornidazole infusion
standard test procedure ornidazole injection
standard test procedure Ondansetron injection
standard test procedure dextrose injection
standard test procedure ciprofloxacin injection
STP and analysis method of Ammonium Chloride
Analysis method of aceclofenac
analysis method of Losartan Potassium and Hydrochlorothiazide
analysis method of Linezolid Dry Syrup
analysis method of Drotaverine Hydrochloride and Mefenamic acid
Analysis method of Ceftriaxone Sodium and Sulbactam sodium Injection
analysis method of Cefepime and Tazobactam Injection
Analysis method of Hydroquinone Cream
Analysis method of Tacrolimus Ointment
Analysis method of Terbinafine HCL Cream
Analysis method of Mometasone Furoate and Fusidic Acid Cream
Analysis method of Disodium Hydrogen Citrate Syrup
Analysis method of Hydroquinone with Tretinoin Cream
Analysis method of Hydroquinone Tretinoin and Mometasone Furoate Cream
Analysis method of Sertaconazole Nitrate Cream
Analysis method of Halobetasol Propionate Cream
Analysis method of Povidone Iodine with Ornidazole Ointment
Analysis method of Eberconazole Cream
Analysis method of Luliconazole Cream
Analysis method of Fluconazole Gel
Analysis method of Ketoconazole Cream
Analysis method of Salbutamol and Choline theophyllinate Syrup
Analysis method of Methylcobalamin Injection
Analysis method of Piroxicam and paracetamol Injection
Analysis method of Alpha Beta Arteether Injection
Analysis method of Enrofloxacin Suspension
Analysis method of Levetiracetam Syrup
Analysis method of Sucralfate suspension
Analysis method of Sucralfate and Oxetacaine Suspension
Analysis method of Quinine Sulphate Suspension
Analysis method of Calcium Carbonate vitamin D3 Zinc Gluconate and Magnesium hydroxide suspension
Analysis method of Suspension of Tribasic Calcium phosphate with vitamin D3 and Vitamin B12
Analysis method of Calcitriol with calcium citrate Suspension
Analysis method of Oxyclozanide and Fenbendazole Suspension
Analysis method of Oxyclozanide and Levamisole Suspension
Analysis method of Triclabendazole and Ivermectin Suspension
Analysis method of Itraconazole Solution
Analysis method of Levocetirizine Dihydrochloride syrup
Analysis method of Iron Calcium Vitamin D3 Folic Acid Vitamin B12 Suspension
Analysis method of Ferrous Ascorbate Cyanocobalamin and Folic Acid Suspension
Analysis method of Ambroxol Hydrochloride Drops
Analysis method of Ferrous Ascorbate with Folic Acid suspension
Analysis method of Piracetam Syrup
Analysis method of Rafoxanide and Levamisole suspension
Analysis method of Zinc gluconate Syrup
Analysis method of Magaldrate Simethicone and Oxetacaine suspension
Analysis method of mefenamic acid and paracetamol suspension
Analysis method of Cholecalciferol Drops
Analysis method of Racecadotril suspension
Analysis method of Deflazacort Suspension
Analysis method of Montelukast sodium and levocetirizine Dihydrochloride Syrup
Analysis method of Iron and Folic Acid Syrup
Analysis method of Cyproheptadine Hydrochloride and Tricholine Citrate Syrup
Analysis method of Levofloxacin Hemihydrate Ornidazole and Vitamin E Solution
Analysis method of Albendazole and ivermectin in oral liquid